REASONS FOR FINAL DECISIONS BY DELEGATESOF THE SECRETARY TO THE DEPARTMENT OF HEALTH AND AGEING FOR AMENDMENTS TO THE POISONS STANDARD

MARCH 2011

Delegates’ final decisions on scheduling matters:

  • Initially referred to the December 2010 joint meeting of the Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS) [ACCS-ACMS#1];
  • Initially referred to the December 2010 meeting of the ACMS [ACMS#1]; or
  • Considered as delegate-only matters i.e. were not referred to an advisory committee.

Notice under subsections 42ZXZS and 42ZCZX of theTherapeutic Goods Regulations 1990 (the Regulations)

Adelegate of the Secretary to the Department of Health and Ageing hereby gives notice of delegates’ final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons – SUSMP) under subsections 42ZCZS and 42ZCZX of the Regulations. This notice also provides the reasons for each decision and the date of effect of the decision. Edited versions of further submissions on matters referred to ACCS-ACMS#1 or ACMS#1 are also available at

Matters referred to ACCS-ACMS#1 and ACMS#1

Delegate’s interim decisions on recommendations by ACCS-ACMS#1 and ACMS#1 were published on 16 February 2011 at This public notice also invited further comment from the applicant and parties who made a valid submission in response to the original invitation for submissions (published 29 September 2010 at

In accordance with subsection 42ZCZR of the Regulations, if a delegate makes an interim decision on an application, that delegate may make a final decision confirming, varying or setting aside the interim decision only after considering any further valid submissions. If no further submissions were received then the delegate may choose to confirm the interim decision as the final decision.

Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate.

Matters not referred to an advisory committee

A delegate may make a final decision on matters the delegate did not choose to refer to an advisory committee. Guidance for the delegate when deciding not to refer a matter to an advisory committee is set out in the Scheduling Policy Framework (SPF) accessible at

Implementation

The amendments arising from this notice will be incorporated into the SUSMP through an amendment which will be available for purchase from National Mailing and Marketing Pty Ltd, telephone (02) 6269 1035. The SUSMP and its amendments are also available electronically at the ComLaw website, a link to which can be found at

Delegates’ reasons for final decisions

March 20111


TABLE OF CONTENTS


GLOSSARY......

PART A – FINAL Decisions on proposals REFERRED TO AN ADVISORY COMMITTEE......

1.Matters Initially referred to aCCS-ACMS#1......

1.15-Aminolevulinic Acid......

1.2Triclosan......

1.3laureth carboxylic acids......

1.4sodium lauryl sulfate......

2.Matters INITIALLY REFERRED to aCMS#1......

2.1Cough and Cold......

2.2Diclofenac......

2.3Mercury / Mercurochrome......

2.4Pseudoephedrine......

PART B – FINAL Decisions on proposals NOT REFERRED TO AN ADVISORY COMMITTEE..

3.1Ethyl alcohol......

3.2Ofatumumab......

3.3Rilpivirine......

3.4Tolvaptan......

3.5Vinflunine......

GLOSSARY

ABBREVIATIONNAME

AANAustralian Approved Name

ACActive Constituent

ACCCAustralian Competition and Consumer Commission

ACCSAdvisory Committee on Chemicals Scheduling

ACCMAdvisory Committee on Complementary Medicines (formerly Complementary Medicine Evaluation Committee [CMEC])

ACMSAdvisory Committee on Medicines Scheduling

ACNPMAdvisory Committee on Non-Prescription Medicines (formerly Medicines Evaluation Committee [MEC])

ACPMAdvisory Committee on Prescription Medicines (formerly Australian Drug Evaluation Committee [ADEC])

ACSMAdvisory Committee on the Safety of Medicines (formerly Adverse Drug Reactions Advisory Committee [ADRAC])

ADECAustralian Drug Evaluation Committee (now Advisory Committee on Prescription Medicines [ACPM])

ADIAcceptable Daily Intake

ADRACAdverse Drug Reactions Advisory Committee (now Advisory Committee on the Safety of Medicines [ACSM])

AHMACAustralian Health Ministers' Advisory Council

APVMAAustralian Pesticides and Veterinary Medicines Authority

AQISAustralian Quarantine and Inspection Service

ARfDAcute Reference Dose

ASCCAustralian Safety and Compensation Council

ASMIAustralian Self-Medication Industry

ARTGAustralian Register of Therapeutic Goods

CASChemical Abstract Service

CHCComplementary Healthcare Council of Australia

CMECComplementary Medicine Evaluation Committee (now Advisory Committee on Complementary Medicines [ACCM])

CMIConsumer Medicine Information

COAGCouncils Of Australian Governments

CRCChild-Resistant Closure

CTFAACosmetic, Toiletry & Fragrance Association of Australia

CWPCodeine Working Party

DAPDrafting Advisory Panel

ECRPExisting Chemicals Review Program

EPAEnvironment Protection Authority

ERMAEnvironmental Risk Management Authority (NZ)

FAISDFirst Aid Instructions and Safety Directions

FDAFood and Drug Administration (US)

FOIFreedom of Information Act 1982

FSANZFood Standards AustraliaNew Zealand

GHSGlobally Harmonised System for Classification and Labelling of Chemicals.

GITGastro-intestinal tract

GPGeneral Practitioner

HCNHealth Communication Network

INNInternational Non-proprietary Name

ISOInternational Standards Organization

LC50The concentration of a substance that produces death in 50% of a population of experimental organisms. Usually expressed as mg per litre (mg/L) as a concentration in air.

LD50The concentration of a substance that produces death in 50% of a population of experimental organisms. Usually expressed as milligrams per kilogram (mg/kg) of body weight

LOAELLowest Observed Adverse Effect Level

LOELLowest Observed Effect Level

MCCMedicines Classification Committee (NZ)

MECMedicines Evaluation Committee (now Advisory Committee on Non-Prescription Medicines [ACNPM])

MOHMinistry of Health (NZ)

NCCTGNational Coordinating Committee of Therapeutic Goods

NDPSCNational Drugs and Poisons Schedule Committee

NHMRCNational Health and Medical Research Council

NICNASNational Industrial Chemicals Notification & Assessment Scheme

NOAELNo Observed Adverse Effect Level

NOELNo Observable Effect Level

NOHSCNational Occupational Health & Safety Commission

OCMOffice of Complementary Medicines

OCSEHOffice of Chemical Safety and Environmental Health

ODBTOffice of Devices, Blood and Tissues

OOSOut of Session

OPMOffice of Prescription Medicine

OTCOver-the-Counter

PACIAPlastics And Chemicals Industries Association

PARPrescription Animal Remedy

PBACPharmaceutical Benefits Advisory Committee

PECPriority Existing Chemical

PGAPharmaceutical Guild of Australia

PHARMPharmaceutical Health and Rational Use of Medicines

PIProduct Information

PICPoisons Information Centre

PSAPharmaceutical Society of Australia

QCPPQuality Care Pharmacy Program

QUMQuality Use of Medicines

RFIRestricted Flow Insert

SCCNFPScientific Committee on Cosmetic and Non-Food Products

SCCPScientific Committee on Consumer Products

STANZHAStates and Territories and New Zealand Health Authorities

SUSDPStandard for the Uniform Scheduling of Drugs and Poisons

SUSMPStandard for the Uniform Scheduling of Medicines and Poisons

SVTFirst aid for the solvent prevails

TCMTraditional Chinese Medicine

TGATherapeutic Goods Administration

TGCTherapeutic Goods Committee

TGOTherapeutic Goods Order

TTHWPTrans-Tasman Harmonisation Working Party

TTMRATrans-Tasman Mutual Recognition Agreement

WHOWorld Health Organization

WPWorking Party

WSWarning statement

Delegates’ reasons for final decisions

March 20111


PART A – FINAL Decisions on proposals REFERRED TO AN ADVISORY COMMITTEE

1.Matters Initially referred to aCCS-ACMS#1

1.15-Aminolevulinic Acid

DELEGATE’S REFERRAL TO EXPERT ADVISORY COMMITTEE

The delegate considered the scheduling of 5-aminolevulinic acid (5-ALA) and decided to seek advice from the December 2010 ACCS-ACMS joint meeting on the following:

5-aminolevulinic acid (5-ALA) – proposal to include in Schedule 4. This proposal is a result of a recommendation from the June 2010 NDPSC meeting.

EXPERT ADVISORY COMMITTEE RECOMMENDATION

The ACCS-ACMS joint meeting recommended that a new Schedule 4 entry be created for 5-ALA. The joint meeting further recommended an implementation date of at least nine months after the delegate’s final decision.

BACKGROUND

Methylaminolevulinate (MAL) is used in photodynamic therapy (PDT) to treat cancerous and pre-cancerous cells. MAL is currently listed in Schedule 4, with no specified cut-offs or use limits. MAL is the methyl ester of 5-ALA.

As 5-ALA is the active principle of MAL, it is expected that it would normally be captured by the Schedule 4 entry of MAL, since a Schedule entry captures “every salt, active principle or derivative of the substance, including esters”, as set out under Part 1(2)(c) of the SUSMP. However, the October 2003 NPDSC meeting determined that, until such time as a product was available in the Australian market, 5-ALA should remain unscheduled. There is no record of any subsequent reconsideration of this position.

In February 2010 the Cosmetic Physicians Society of Australia (CPSA)raised the following concerns with the TGA about the scheduling status of 5-ALA and its current use by beauty therapists for PDT:

  • PDT was promoted for treatment of sun-damaged skin within the beauty profession without the relevant medical and clinical guidelines; and
  • because 5-ALA was unscheduled, non-medical personnel can provide skin cancer treatment to the general public without the appropriate training, diagnostic skills, follow-up or monitoring.

The scheduling of 5-ALA was subsequently referred to the June 2010 NDPSC meeting for consideration. The NDPSC decided that it would be appropriate to include 5-ALA in Schedule 4. Members noted, however, that a number of pre-meeting submissions opposed this decision and, in accordance with the transition arrangements for this final meeting of the NDPSC, agreed that this item could not be finalised at that meeting. The NDPSC therefore referred the matter to the delegate with the recommendation that a new Schedule 4 entry for 5-ALA be created.

SCHEDULING STATUS

As detailed above, not currently scheduled.

INITIAL SUBMISSIONS

December 2010 Pre-meeting Submissions

A single pre-meeting submission was received from the CPSA supporting that 5-ALA (and any of its derivatives and related compounds) used as photosensitising agents in PDT should be captured in Schedule 4.

The submission reiterated the following arguments, as presented in CPSA’s February 2010 letter to TGA and subsequent premeeting submission to the June 2010 NDPSC meeting

  • PDT is generally conducted by doctors to treat precancerous and some forms of cancerous skin lesions.
  • Having 5-ALA unscheduled allows beauty therapists to access this substance at any strength (the medical strength 5-ALA was usually 20 per cent). This 5-ALA may also be a non-stabilised form which can lead to a variability of concentration and penetration with consequent unpredictability of results and potential side effects.
  • One example of a beauty therapy training course for PDT claimed to use 5-ALA at a cosmetic strength of about 3 per cent.
  • Beauty therapy training does not provide the individual with the ability to correctly examine, diagnose or treat advanced sun-damaged skin. The ability to biopsy for histopathological diagnosis of suspicious lesions before the appropriate treatment is prescribed is not within the beauty therapy skill base.
  • Beauty therapists do not have professional indemnity insurance cover commensurate with that of a medical practitioner to safeguard potential clients.
  • PDT is being promoted for the treatment of sun-damaged skin within the beauty therapy profession without the relevant medical and clinical guidelines. In Australia there is a distinct possibility of pre-cancerous and cancerous lesions being present.
  • PDT is not a comfortable experience at therapeutic levels. The CPSA was concerned about aftercare, follow-up and pain management for those individuals who undergo this treatment.
  • The application of PDT-type procedures may not be appropriate for the “skin condition” being treated due to inaccurate diagnosis.
  • Treatment in a beauty therapy environment may lead the patient to believe they are adequately treated for their sun-damage, which in turn may lead to a false sense of security and delayed presentation to a medical practitioner. Correct diagnosis and treatment may then require a more involved medical intervention perhaps with now-necessary mutilation and increased overall health care costs.
  • There are currently no advertising restrictions applying to beauty therapists which are equivalent to those imposed on the medical profession. This may lead to a series of false or exaggerated treatment claims, further enticing and confusing the individual considering such treatments.
  • A Schedule 4 listing would increase public safety through increased likelihood of correct diagnosis and appropriate treatment and management of skin conditions.

Implementation

  • A delayed implementation period was not recommended as this would leave potential clients of non-medically trained individuals open to harm by incorrect diagnosis and treatments of sun-damage.

June 2010 NDPSC discussion

Members noted the discussion of the June 2010 NDPSC meeting, including the following particular points.

  • A Member asserted that the extent of non-medical use of 5-ALA was difficult to determine and the risks and benefits of use of this substance in this context should be considered in making a scheduling decision. The Member specifically noted the risk of potentially delaying diagnosis of cancer in relation to potential aesthetic benefits.
  • A Member argued that a scheduling decision must be based on the inherent risk of the substance and not be used to restrict access in a particular setting without appropriate toxicological data to support that restriction. The Member also cautioned that there were different uses of the term “sun-damaged skin” which was contributing to the confusion in this debate. For the beauty profession, this often meant “signs of ageing” such as wrinkles, whereas for the medical profession, the term usually related to skin in a “pre-cancerous” condition.
  • A Member stated that, given there are products containing 5-ALA currently available on the Australian market, the October 2003 NDPSC decision to leave 5-ALA unscheduled “until such time as a product was available in the Australian market” was no longer appropriate. The Member also noted that XXXXX supported a Schedule 4 listing.
  • A Member asserted, and the NDPSC generally agreed, that 5-ALA should, by any objective determination, be captured by the Schedule 4 MAL entry. The NDPSC agreed to recommend a new Schedule 4 entry for 5-ALA.

June 2010 NDPSC submissions

Members noted the information submitted for consideration by the June 2010 NDPSC meeting, including the following particular points.

  • Eleven pre-meeting submissions were considered, nine of which were in support of a Schedule 4 entry for 5-ALA. However, one of the opposing submissions included letters from seven beauty therapists/clinics also opposed to a Schedule 4 listing.

Submissions in favour of Schedule 4

  • The CPSA reiterated a number of points raised in their initial letter to the TGA and further highlighted the lack of training of beauty therapists to adequately diagnose or treat sun-damaged skin. The submission also discussed the types of lesions that are able to be treated by PDT in order to highlight the need for professional intervention. This submission was endorsed by submissions from XXXXX.
  • A number of medical specialists/clinics also supported Schedule 4, noting:

concern over correct diagnosis of potential skin cancers before undertaking PDT;

alarm that beauty therapists, who had minimal training in the treatment and recognition of skin cancer, have access to 5-ALA; and

that interactions with medications, such as tetracycline antibiotics, griseofulvin and diuretics, were of particular concern as it was common for patients seeking PDT to be taking these medications.

Submissions opposed to Schedule 4

  • XXXXX argued that there was no scientific basis for the restriction of PDT due to perceived threat to public safety. The following points were noted by Members.

Beauty therapists are made aware of the potential for a client to present with skin cancers through training and will seek medical advice before treating any skin with abnormalities.

5-ALA enhances the effects of laser, intense pulse light (IPL) and light emitting diode (LED) treatments and these treatments have been used safely for years.

XXXXXdoes not train in the removal of skin cancers with PDT. This is a different treatment protocol that is left strictly to the medical profession. Training stipulates that any pigmented skin be medically assessed for skin cancer and cleared before PDT skin rejuvenation treatments are offered.

The vast majority of “non-medical” health practitioners freely and swiftly refer clients to doctors for assessment and treatment where there is even the slightest possibility of a skin cancer condition.

XXXXXstrongly opposed the scheduling of 5-ALA as it would severely limit public access to a safe and effective treatment offered by the wider aesthetic industry.

  • XXXXX disputed the need for scheduling on the grounds of public safety for 5-ALA, arguing that the proposal was based on a business focus of some medical groups. Members noted that XXXXX had:

discussed clinical applications, methods of application, public benefits and risks and the commercial pressure that XXXXX asserted were influencing doctor statements;

included letters from seven beauty therapists with experience using PDT and

5-ALA, all supporting the position that 5-ALA should not be scheduled;

referred to a literature review of PDT(commissioned by XXXXX) and asserted that this located all known literature worldwide to identify any possible side effects and complications. Broadly speaking, there were few reports of significant adverse outcomes using 5-ALA in PDT. Two cases of skin cancer possibly related to PDT have been reported. The report also statedthat PDT was generally considered to have a low risk of carcinogenicity;

asserted that there have been no serious adverse events reported to date by either beauty therapists or doctors in Australia or NZ using 5-ALA for PDT;

asserted that doctors were often uncertain as to the correct clinical parameters on the use of PDT and the “learning curve” was considered a lengthy one. However, with correct clinical training and access to TGA listed (or registered) light devices, a health practitioner could rapidly become competent and extremely safe in the patient assessment and use of PDT treatment;

advised that, based on some simple survey sampling, the total number of Australian clinics offering PDT to the public may be around 200 to 240 centres (primarily medical clinics). These clinics appear to prefer using 5-ALA rather than the more aggressive MAL, primarily used by a small number of dermatologists specifically for treatment of cancerous and pre-cancerous tissues identified in patients;

asserted that it is widely accepted by doctors, and others, that PDT has an extremely low risk profile and is an ideal tool for a variety of skin conditions and complaints, some medical and others not;